Bridgewater, NJ, United States
Bausch Health Companies, Inc. recalls
4 recalls recorded since 2018, most recently on 2 February 2024. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)0
Terminated or completed4
Class I (FDA)0
Completed Class II Drugs
- Recall started
- 2 February 2024
- Reason
- Subpotent Drug: Out of specification for assay
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0355-2024
- Omeprazole and Sodium Bicarbonate For Oral Suspension 40mg/1,680mg, This packet contains 40mg of omeprazole and 1,680mg of sodium bicarbonate, Directions for Use: Empty packet contents into a small cup containing 1 to 2
Terminated Class III Drugs
- Recall started
- 8 June 2021
- Terminated
- 16 February 2023
- Reason
- Failed Impurities/Degradation Specifications
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0638-2021, D-0639-2021
- Mephyton (Phytonadione) 5 mg tablets, 100-count tablets, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC, Bridgewater, NJ, 08807, USA, NDC 0187-1704-05.
- Phytonadione Tablets, 5 mg, 30-count ablets, Rx only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA, NDC 68682-170-30
Terminated Class III Drugs
- Recall started
- 7 January 2021
- Terminated
- 11 February 2022
- Reason
- Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
- Distribution
- Distributed Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0244-2021, D-0243-2021
- Phytonadione Tablets 5mg, 30-count bottle, Rx Only, Manufactured For: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA NDC 68682-170-30
- Mephyton (phytonadione) Tablets 5mg, 100-count bottle, Rx Only, Manufactured for: Valeant Pharmaceuticals North America, LLC Bridgewater, NJ 08807 USA NDC 0187-1704-05
Terminated Class II Drugs
- Recall started
- 13 July 2020
- Terminated
- 3 March 2022
- Reason
- SUBPOTENT DRUG
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0054-2021
- Hydrocortisone butyrate Cream, 0.1%, 15-gram tubes, Rx Only, Manufactured for Oceanside Pharmaceuticals a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA, By: Ferndale Laboratories, Inc. F
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.